The FDA drug epidemic does not stand up to inspection

Before announcing his resignation last week, FDA Commissioner Scott Gottlieb made the fight against teenage vaping a central goal of his mandate. Determined to eliminate what he often called an "epidemic," regulators have not only exaggerated the magnitude of the problem, but have also threatened retailers with regulatory repercussions. The source of the problem is elsewhere.

For e-cigarette opponents concerned about protecting children, there is no too much regulatory burden. On Wednesday, Gottlieb delivered on his promise of "strong enforcement action" against tobacco retailers selling to underage customers. He announced a draft policy of compliance with these expectations: "Some flavored electronic cigarette products will no longer be sold at all … other flavored electronic cigarette products that continue to be sold will only be sold in such a way as to prevent youth access … some flavored products cigars will no longer be sold.

Gottlieb last week prepare the terrain by calling the Walgreens management, as well as other national gas stations and convenience stores such as Exxon, 7-Eleven and Walmart. Using hard language, he described the "FDA field presence across the country," recalling "the historic event of the … inspection of a million tobacco retailers" since 2010, which resulted in tens of thousands of warning letters, almost 20,000 penalties and 145 "no-smoking orders".

Federal data reveal important information, however, that contradicts the FDA's announcement and the perception that teenage vaping is an ubiquitous problem. According to the 2017 National Youth Smoking Survey conducted by the Centers for Disease Control and Prevention, only about 12 per cent of US high school students have used e-cigarettes in the past month. Although the CDC observation – based on unpublished data – is correct about an increase in vaping in 2018, it does not confirm an epidemic. Nearly 70% of students who drank – but did not smoke – used electronic cigarettes five days or less during this 30-day period, which was called "party" or "weekend", but not regular daily consumption.

Another federal survey, "Monitoring the Future," reveals more critical adolescent epidemics: alcohol and marijuana use. Thirty percent of high school graduates consume alcohol and 18 percent said they were drunk in the last month. Similarly, 22% of students report using marijuana – a level that has remained stable since 1995. Unlike vaping, which is considered to be 95% safer than smoking and does not affect judgment or inhibitions, teens too often die of accidents related to the use of marijuana and alcohol.

Although the FDA pointed to retailers, only a tiny fraction of American teenagers who used electronic cigarettes bought them on their own. The FDA's survey data confirm this. The Population Assessment of Tobacco and Health survey (or PATH) collects detailed information on adolescent smoking. It reveals that less than 10% of current teen e-cigarette users – generally defined as having taken at least one puff in the last 30 days – "bought them myself". In short, most teens do not receive e-cigarettes from retailers. ready to break the law for an extra dollar. Instead, they buy electronic cigarettes in the old – through friends.

The FDA's exaggeration is particularly due to the fact that it relies on data manipulation. The FDA has stated that 22% of Walgreens stores have been illegally selling tobacco products to minors since 2010; and 14 other national retail chains registered infringements of 15% to 44%. These extremely high figures are, however, the result of accumulative mathematics over a period of nine years. A closer look at the data reveals that there was a 12% nationwide violation rate in 2018, barely 1% higher than in 2015-2016. The Walgreens rate was 9%, three points lower than the national average.

While the FDA is obsessed with e-cigarettes, only 19% of the 17,500 offenses cited in 2018 were for these products, far ahead of cigars (44%) and cigarettes (33%). The focus on retailers also does not take into account the wide variation in law violation rates, ranging from Georgia (2.2%) to Montana (2.7%) to Hawaii (3%). %) and California (4.2%) up to North Dakota, Michigan, Ohio and Nevada. at 23 percent.

In addition, the FDA should take into account the different compliance rates of states and what some states are already doing to reduce the use of minors. Seven have passed laws raising the minimum age for the purchase of tobacco from 18 to 21 years. This type of regulation, like a law passed in Virginia last month, aims to dispel adolescence by interrupting the informal black market in high schools. Currently, 14% of American high school students are 18 years old or older. They can legally buy tobacco products and serve as the main source for all other high school students. Tobacco 21 will not eliminate teenage vaping, but it will create another barrier for underage users. Alcohol consumption among teens is still a problem, but Alcohol 21 has played a role in reducing prevalence by almost half. Tobacco 21 does not restrict adult smokers' access to life-saving alternatives to smokeless cigarettes.

We all want teenagers to have a healthy lifestyle, but federal and state policies must be dictated by facts and not by hyperbolic statements. A change of direction to the FDA (Gottlieb will leave in a month) opens an opportunity to reconsider the regulatory approach to e-cigarettes. If we focus on reasonable solutions, rather than on expensive regulations, everyone, including adult smokers, will benefit.